Prince Philip Hospital, Carmarthenshire NHS Trust, Mawr Dafen, Llanelli, UK.
J Orthop Surg Res. 2011 Aug 24;6:45. doi: 10.1186/1749-799X-6-45.
Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome.
A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.
Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.
The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group.
全膝关节置换（TKR）后充分的术后止痛对术后的最佳恢复非常重要。更快的活动和康复最终会导致最佳的恢复效果，但疼痛往往是限制因素。本研究评估了 InterX 神经刺激器在减轻疼痛和康复效果方面的潜在临床益处。
在 Hywel Dda 临床审计委员会下进行了一项临床试验，以验证使用 InterX 设备进行非侵入性互动神经刺激（NIN）治疗的临床益处，该试验在接受 TKR 的患者中进行。61 名患者按照手术名单中的两个一组进行随机分组。对照组在术后 3 天内每天接受两次标准的医院疼痛药物和康复治疗。实验组在接受对照组标准疗程的基础上，额外接受 3 次术后 8 次 NIN 治疗。疼痛和活动范围作为主要研究指标。
共纳入 61 名受试者并进行随机分组，但因基线/最终数据缺失，2 名受试者（每组 1 名）被排除；InterX 组的 1 名受试者因术前存在类风湿性疼痛状况而被排除，使分析受到干扰。实验组治疗前后的疼痛语言评分量表（VRS）显示，NIN 治疗持续将疼痛评分降低 2.3 分（SE 0.11）。最终的 NIN 预处理评分用于主要的协方差分析比较，显示出显著更大的累积治疗效果，平均疼痛减轻 2.2（SE 0.49）分（p=0.002）。对照组仅经历了平均 0.34（SE 0.49）点的疼痛减轻。90 度 ROM 是患者出院的要求，尽管 InterX 组的基线缺陷更大，但仍平均达到了这一要求。8 名对照组患者和 3 名实验组患者未达到这一 ROM。
结果清楚地表明了 NIN 治疗作为标准康复方案的补充的临床益处。接受 InterX 的患者在临床方面表现明显更好。在相对较短的 3 天时间内，实验组患者获得了出院所需的 ROM，且疼痛水平低于对照组。
